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November 22, 2015

Baxalta seeks UK MHRA approval for BAX 826 trial of to treat hemophilia A

US-based biopharmaceutical firm Baxalta has submitted a clinical trial application (CTA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) seeking approval to start a first-in-human clinical trial of BAX 826, an investigational, extended half-life recombinant Factor VIII (rFVIII), to treat hemophilia A.

US-based Baxalta has submitted a clinical trial application (CTA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), seeking approval to start a first-in-human clinical trial of BAX 826.

BAX 826 is an investigational, extended half-life recombinant Factor VIII (rFVIII), and a potential treatment for hemophilia A.

The open-label trial will enrol about 30 patients, and evaluate the safety and efficacy of BAX 826.

"The CTA submission represents an important advancement in our efforts to expand our portfolio."

Baxalta intends to start treating participants with BAX 826 in early 2016.

The company noted that BAX 826 is modified using proprietary polysialic acid (PSA) technology, licensed from Xenetic Biosciences, to extend its circulating half-life.

Baxalta have partnered with Xenetic to develop new forms of polysialylated blood coagulation factors, including factor VIII.

According to preclinical studies, BAX 826 offered an extended half-life compared to standard rFVIIIs.

Baxalta Research & Development head and chief scientific officer John Orloff said: "We are advancing a number of approaches, including BAX 826 as well as our gene therapy programme, to evaluate potential new options for hemophilia patients that can offer efficacy while also easing the treatment burden with a goal of once-weekly or even less frequent infusions.

"The CTA submission represents an important advancement in our efforts to expand our portfolio of extended half-life treatments, and further reinforces our leadership in hemophilia innovation."

With the BAX 826 programme, Baxalta intends to augment its growing portfolio of direct-factor replacement treatments for hemophilia.

The company continues to develop new advances, such as gene therapy, which has the potential to transform the treatment of hemophilia.

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